BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 3182389 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-05859
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY FROM HER LEAD. THE REASON MIGHT BE DUE TO THE LEAD INITIALLY BEING IMPLANTED TOO FAR OVER. THE PATIENT MAY MEET WITH AN SJM REPRESENTATIVE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271965 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3826109

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR SCS IPG: MODEL 3788| IMPLANT: